AcnePhase 3NCT02651220
Clinical End Point Study of Generic Adapalene and Benzoyl Peroxide Gel Versus Epiduo® Forte Gel in Treatment of Acne Vulgaris
A Phase 3 study testing Epiduo® Forte Gel and Adapalene and Benzoyl Peroxide Gel in people with Acne, run by Actavis Inc. at 20 sites in 2 countries.
Trial summary
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence and Safety of adapalene and benzoyl peroxide gel, 0.3%/2.5% (Actavis Laboratories UT, Inc.) to Epiduo® Forte (adapalene and benzoyl peroxide) gel 0.3%/2.5% (Galderma) in the treatment… Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- Epiduo® Forte Gel and Adapalene and Benzoyl Peroxide Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,001 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Nov 2015to Oct 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male or non-pregnant, non-lactating female, ≥ 12 and ≤ 40 years of age with a clinical diagnosis of acne vulgaris.
- Signed informed consent form that meets all criteria of current FDA regulations. For a patient considered to be a minor in the state he/she lives and is enrolled, the patient parent or legal guardian will be required to sign the consent form and the patient will sign an IRB approved "assent to participate" form.
- Females of child bearing potential must not be pregnant or lactating at Visit 1 (as confirmed by a negative urine pregnancy test with a sensitivity of less than 25 mlU/mL or equivalent units of human chorionic gonadotropin). Women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, IUD, a double-barrier method [such as condom plus diaphragm with spermicide], oral, transdermal, injected or implanted non- or hormonal contraceptive), throughout the study. If the female is using a hormonal contraceptive, the same product must be taken for 3 months prior to Visit 1 and must agree not to replace with some other hormonal contraceptives during the study. A sterile sexual partner is not considered an adequate form of birth control.
- All females will be considered to be of childbearing potential unless they:
- Are post-menopausal, defined as women who have been amenorrheic for at least 12 consecutive months, without other known or suspected primary cause.
- Have been sterilized surgically or who are otherwise proven sterile (i.e., total hysterectomy, or bilateral oophorectomy) with surgery at least 4 weeks prior to Screening. Tubal ligation will not be considered a surgically sterile method.
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- Female patients of childbearing potential are defined as:
- Females without prior hysterectomy, or who have had any evidence of menses in the past 12 months.
- Females who have been amenorrhea for ≥ 12 months, but the amenorrhea is possibly due to other causes, including prior chemotherapy, anti-estrogens, or ovarian suppression.
- Have facial acne vulgaris with: ≥ 20 inflammatory lesions (i.e., papules and pustules) and ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) and ≤ 2 nodulocystic lesions (i.e., nodules and cysts).
- Have an Investigator's Global Assessment (IGA) score of 3 or 4 (see Appendix A).
- Willing to comply with the study requirements and restrictions including refraining from the use of all other topical acne medications or antibiotics during the 12 week treatment period.
- Patients who use make-up must have used the same brands/types for a minimum period of 14 days before study entry and must agree to not change brand/type or frequency of use throughout the study.
Who cannot join
- Patient has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory and non-inflammatory lesion count for analysis.
- Patient has active cystic acne.
- Patient has acne conglobata, acne fulminans, or acne vulgaris requiring systemic treatment.
- Patient has a skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, bacterial folliculitis).
- Patients with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.
- Patients with tattoos or excessive facial scarring that, in the Investigator's opinion, may interfere with the evaluation of the patient's acne.
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- Patients with active facial sunburn, peeling from sunburn, or patients that will be exposed to excessive sunlight during the study.
- Females who are pregnant, lactating or likely to become pregnant during the study.
- History of allergy or hypersensitivity to adapalene, retinoids, benzoyl peroxide or history of any drug hypersensitivity or intolerance that, in the Investigator's opinion, would compromise the safety of the patient or the study.
- Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that, in the Investigator's opinion, would place the study participant at undue risk by participation.
- Use of the following on the face within 1 month before Screening/Baseline:
- Cryodestruction or chemodestruction
- Dermabrasion
- Photodynamic therapy
- Acne surgery
- Intralesional steroids
- X-ray therapy
- Use of the following within 1 month before Screening/Baseline:
- Spironolactone
- Systemic steroids
- Systemic antibiotics
- Systemic anti-inflammatory agents (the use of acetylsalicylic acid for prophylactic use up to 325 mg/day is allowed, provided that the patient is on a stable dose and the regimen will remain constant throughout the study). Acetaminophen will be allowed during the study with a maximum dose of 1g (i.e., 1000 mg) twice daily and for a maximum of 3 consecutive days (its use is not allowed within 1 week of each visit).
- Systemic treatment for acne vulgaris (other than oral retinoids that require a 6 month washout), including anti-androgens.
- Use of oral isotretinoin (Accutane®) or oral retinoids within 6 months, or therapeutic vitamin A supplements greater than 10,000 units/day (multivitamins are allowed).
- Use of the following on the face within 2 weeks before Screening/Baseline:
- Topical steroids
- Topical retinoids
- Topical zinc
- Topical anti-inflammatory agents (including salicylic acid)
- Topical antibiotics (including antibacterials)
- Benzoyl peroxide
- Any other topical over-the-counter preparations for acne treatment
- Use of the following on the face within 1 week before Screening/Baseline:
- Phototherapy devices for acne (e.g., ClearLightTM)
- Medicated cleansers including adhesive cleansing strips
- Cosmetic procedures (i.e., facials, peeling, comedone extraction) and alpha-hydroxy/glycolic acid
- Receipt of any drug as part of a research study within 30 days.
- Female patients taking hormonal contraceptives or oral estrogen for less than three months and those that plan to change the dosage regimen during the course of the study.
- Previous participation in this study.
- Employees of the Investigator or research center or their immediate family members.
- Patients who are illiterate.
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States18 sites
Site 112
Anaheim, California, 92804
Site 102
Arlington Heights, Illinois, 60005
Site 101
Brandon, Florida, 33511
Site 105
Carmel, Indiana, 46032
Site 107
Henderson, Nevada, 89052
Site 106
High Point, North Carolina, 27262
Site 119
Jacksonville, Florida, 32256
Site 110
Long Beach, California, 90813
Site 111
Los Angeles, California, 92210
Site 103
Mesa, Arizona, 85202
Site 114
Miami, Florida, 33015
Site 115
Miami, Florida, 33175
Site 116
Miramar, Florida, 33027
Site 120
New Albany, Indiana, 47150
Site 108
Rhinelander, Wisconsin, 54501
Site 104
San Diego, California, 92108
Site 109
Tucson, Arizona, 85712
Site 113
West Covina, California, 91790
Belize2 sites
Site 117
Belize City
Site 118
Belize City
About this study
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence and Safety of adapalene and benzoyl peroxide gel, 0.3%/2.5% (Actavis Laboratories UT, Inc.) to Epiduo® Forte (adapalene and benzoyl peroxide) gel 0.3%/2.5% (Galderma) in the treatment of Acne Vulgaris
Read the detailed description
Up to 1000 patients 12 to 40 years of age inclusive will be enrolled to have 870 patients in the modified intent-to-treat (mITT) population and 579 patients in the per-protocol (PP) population. The primary inclusion criteria are the presence of ≥ 20 inflammatory lesions (papules and pustules) and ≥ 25 non-inflammatory lesions (opened and closed comedones) and ≤ 2 nodulocystic lesions (i.e., nodules and cysts) on the face and an Investigator's Global Assessment (IGA) score of 3 or 4.
Eligible patients will be randomized in a 1:1:1 ratio to one of the three treatments (Test, Reference or Placebo) on Visit 1. Patients will be instructed to apply the first treatment on the evening of enrollment into the study and then continue to apply once daily for the next 83 days (for a total 84 days). Patients will attend the following scheduled clinic visits:
- Visit 1 - Screening/Baseline: Day 1
- Visit 2 - Interim Visit: Day 28 ± 4
- Visit 3 - Interim Visit: Day 56 ± 4
- Visit 4 - End of Study: Day 85 ± 4 Efficacy evaluations will be based on dermatological assessments in the clinic. The primary statistical analyses of interest are (1) the percent change from baseline to Week 12 in the number of inflamed (papules/pustules) lesions and non-inflamed (open and closed comedones) lesions. In addition, patients will also be evaluated by the Investigator to determine "Clinical Success" or "Clinical Failure" at Week 12
- Conditions
- Acne
- Being tested
- Epiduo® Forte Gel, Adapalene and Benzoyl Peroxide Gel, placebo gel
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epiduo® Forte GelDrug
Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
Adapalene and Benzoyl Peroxide GelDrug
Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
placebo gelDrug
vehicle used as placebo
| Study group | Role | What they receive |
|---|---|---|
| Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w | Experimental | Not described Receives: Drug: Adapalene and Benzoyl Peroxide Gel |
| Epiduo® Forte Gel 0.3%/2.5% w/w | Active comparator | Not described Receives: Drug: Epiduo® Forte Gel |
| Placebo (vehicle) Topical Gel | Placebo comparator | Not described Receives: Drug: placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline to Week 12 in the Number of Inflamed Lesions.
Measured: 12 weeks
Percent Change From Baseline to Week 12 in the Number of Non-inflamed Lesions.
Measured: 12 weeks
Secondary outcomes (1)
Percentage of Patients With a Clinical Response of "Clinical Success" Using the Investigator's Global Assessment (IGA) at Week 12
The Investigator's Global Assessment had to show a score of 0 (clear) or 1 (almost clear) to be considered a "Clinical Success".
0= Clear skin with no inflammatory or non inflammatory lesions.
- Almost clear, rare non-inflammatory lesions with no more than one small inflammatory lesion.
- Mild severity; greater than Grade 1; some non inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions).
- Moderate severity; greater than Grade 2; up to many non inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion.
- Severe; greater than Grade 3, up to many non inflammatory lesions and may have some inflammatory lesions, but no more than a few nodular lesions.
- Very severe, greater than Grade 4
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startNov 2015
- Primary completionApr 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,001 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651220
- Sponsor's protocol ID
- 71491705
- Status last verified
- Jun 2020
- First submitted
- 5 Jan 2016
- Last updated
- 23 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical End Point Study of Generic Adapalene and Benzoyl Peroxide Gel Versus Epiduo® Forte Gel in Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02651220
- Acronym / sponsor ID
- 71491705
- Conditions
- Acne
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,001 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Posted 23 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence and Safety of adapalene and benzoyl peroxide gel, 0.3%/2.5% (Actavis Laboratories UT, Inc.) to Epiduo® Forte (adapalene and benzoyl peroxide) gel 0.3%/2.5% (Galderma) in the treatment of Acne Vulgaris
Detailed description
Up to 1000 patients 12 to 40 years of age inclusive will be enrolled to have 870 patients in the modified intent-to-treat (mITT) population and 579 patients in the per-protocol (PP) population. The primary inclusion criteria are the presence of ≥ 20 inflammatory lesions (papules and pustules) and ≥ 25 non-inflammatory lesions (opened and closed comedones) and ≤ 2 nodulocystic lesions (i.e., nodules and cysts) on the face and an Investigator's Global Assessment (IGA) score of 3 or 4.
Eligible patients will be randomized in a 1:1:1 ratio to one of the three treatments (Test, Reference or Placebo) on Visit 1. Patients will be instructed to apply the first treatment on the evening of enrollment into the study and then continue to apply once daily for the next 83 days (for a total 84 days). Patients will attend the following scheduled clinic visits:
- Visit 1 - Screening/Baseline: Day 1
- Visit 2 - Interim Visit: Day 28 ± 4
- Visit 3 - Interim Visit: Day 56 ± 4
- Visit 4 - End of Study: Day 85 ± 4 Efficacy evaluations will be based on dermatological assessments in the clinic. The primary statistical analyses of interest are (1) the percent change from baseline to Week 12 in the number of inflamed (papules/pustules) lesions and non-inflamed (open and closed comedones) lesions. In addition, patients will also be evaluated by the Investigator to determine "Clinical Success" or "Clinical Failure" at Week 12
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w | Experimental | Drug: Adapalene and Benzoyl Peroxide Gel |
| Epiduo® Forte Gel 0.3%/2.5% w/w | Active comparator | Drug: Epiduo® Forte Gel |
| Placebo (vehicle) Topical Gel | Placebo comparator | Drug: placebo gel |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Male or non-pregnant, non-lactating female, ≥ 12 and ≤ 40 years of age with a clinical diagnosis of acne vulgaris.
- Signed informed consent form that meets all criteria of current FDA regulations. For a patient considered to be a minor in the state he/she lives and is enrolled, the patient parent or legal guardian will be required to sign the consent form and the patient will sign an IRB approved "assent to participate" form.
- Females of child bearing potential must not be pregnant or lactating at Visit 1 (as confirmed by a negative urine pregnancy test with a sensitivity of less than 25 mlU/mL or equivalent units of human chorionic gonadotropin). Women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, IUD, a double-barrier method [such as condom plus diaphragm with spermicide], oral, transdermal, injected or implanted non- or hormonal contraceptive), throughout the study. If the female is using a hormonal contraceptive, the same product must be taken for 3 months prior to Visit 1 and must agree not to replace with some other hormonal contraceptives during the study. A sterile sexual partner is not considered an adequate form of birth control.
- Have facial acne vulgaris with: ≥ 20 inflammatory lesions (i.e., papules and pustules) and ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) and ≤ 2 nodulocystic lesions (i.e., nodules and cysts).
- Have an Investigator's Global Assessment (IGA) score of 3 or 4 (see Appendix A).
Key exclusion criteria (41 listed)
- Patient has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory and non-inflammatory lesion count for analysis.
- Patient has active cystic acne.
- Patient has acne conglobata, acne fulminans, or acne vulgaris requiring systemic treatment.
- Patient has a skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, bacterial folliculitis).
- Patients with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epiduo® Forte GelAdapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w | Drug | Epiduo® Forte Gel 0.3%/2.5% w/w |
| Adapalene and Benzoyl Peroxide GelAdapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w | Drug | Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w |
| placebo gelvehicle used as placebo | Drug | Placebo (vehicle) Topical Gel |
Primary outcome
Percent Change From Baseline to Week 12 in the Number of Inflamed Lesions.
Time frame: 12 weeks
Percent Change From Baseline to Week 12 in the Number of Non-inflamed Lesions.
Time frame: 12 weeks
1 secondary outcome
Percentage of Patients With a Clinical Response of "Clinical Success" Using the Investigator's Global Assessment (IGA) at Week 12
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epiduo® Forte Gel and Adapalene and Benzoyl Peroxide Gel in people with Acne, run by Actavis Inc. at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Belize. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline to Week 12 in the Number of Inflamed Lesions. (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.